Clearance Summary
BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020 received FDA 510(k) clearance under submission number K061162, sponsored by Applied Spine Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2006-07-26.
- Submission: K061162
- Applicant / Sponsor: Applied Spine Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2006-07-26
Classification & Regulation
This clearance is catalogued under FDA product code MNH and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.